An interventional study of 3D-Colonoscopy Progression Score and Endoscopy Training System in Education, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Other
A cross validation study comparing an international acknowledged assessment tool "Endoscopy Training System" (ETS) and movement analysis of the colonoscope based on raw data from coils within the scope.
24 physicians are recruited and divided based on experience (novices and experienced). All participants are to perform twice on the ETS that is based on four tasks; Scope manipulation, tool targeting, loop management and mucosal inspection. The movement of the colonoscope will be gathered during the tasks and correlated to the scores of the ETS.
24 physicians are recruited on a voluntarily basis, and will be divided into two groups, based on experience;
Novice group:
Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies.
Experienced group:
Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists.
Demographic data will gathered from all three groups as follows:
Performance metrics:
Loop Management (LM) - The management of a standard alfa-loop. If during insertion from anus until cecum a loop is formed, it must be first recognised and then unlooped successfully to continue advancing the colonoscope.
The Colonoscopy Training Model begin in the left lateral position, but on request, the model can be repositioned in the supine, prone, or right lateral decubitus position. On request, abdominal pressure can be provided when directed by the participant.
The 3D-Colonoscopy Progression Score (3D-CoPS) and the 3D-Colonoscopy Retraction Score (3D-CoRS) are movement analysis. Electromagnetic coils are built in along the length of the Olympus colonoscopes. They generate a pulsed low-intensity magnetic field that is picked up a receiver coil. The data-points for each coil are inserted into an algorithm for movement analyzing. This analysis is done as a change between the tip of the scope, and the next tracked magnetic coil. The result is a relative movement of the colonoscope in relation to the previous position, and how much the movement is deflected according to the direction the tip points in. This movement analysis is used for distinction between the progression- and retraction phase, and as the basis for the 3D-CoPS and 3D-CoRS analysis, which is essential, such that the 3D-CoRS measurements is performed during withdrawal of the colonoscope.
Exclusion Criteria:
Any physician who has no experience of endoscopies or has done no more than 50 colonoscopies. Each subject included are to perform on the Endoscopy Training System (ETS) during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
Other: 3D-Colonoscopy Progression Score · Other: Endoscopy Training System · Other: 3D-Colonoscopy Retraction Score
Includes any physician who have succeeded more than 140 colonoscopies. Professional backgrounds include surgeons and gastroenterologists. Each subject included are to perform on the ETS during which data for 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score is gathered.
Other: 3D-Colonoscopy Progression Score · Other: Endoscopy Training System · Other: 3D-Colonoscopy Retraction Score
3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
Also known as: 3D-CoPS
The Endoscopy Training System is based on the Colonoscopy Training Model platform and includes four different performance metrics and a scoring system. 1. Scope Manipulation - The use of torque and tip deflection to move a shape in the colon 2. Tool Targeting - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched. 3. Loop Management - The management of a standard alfa-loop. 4. Mucosal Inspection - Randomly placed polyps inside the rubber colon have to be found during withdrawal.
Also known as: ETS
3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
Also known as: 3D-CoRS
3D-Colonoscopy Progression Score
The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000 .A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.
Time frame: 3 months
3D-Colonoscopy Retraction Score
The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.
Time frame: 3 months
Relationship to other variables
Scores from the ETS, 3D-CoPS and 3D-CoRS will be correlated.
Time frame: 3 months
Plan to share: No
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Rigshospitalet, Denmark